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Serving 500+ biopharmaceutical companies globally:

Novartis
US Army
AstraZeneca
McKesson
UBS
Daiichi Sankyo
Cipla
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Boehringer Ingelheim
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Generated: June 28, 2017

DrugPatentWatch Database Preview

Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has four hundred and seventy-six patent family members in forty-six countries.

There are ten drug master file entries for lenalidomide. One supplier is listed for this compound.

Summary for Generic Name: lenalidomide

Tradenames:1
Patents:28
Applicants:1
NDAs:1
Drug Master File Entries: see list10
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list727
Patent Applications: see list508
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lenalidomide at DailyMed

Pharmacology for Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo8,741,929► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo9,101,621► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo7,855,217► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo7,465,800► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20056,281,230► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 20118,288,415► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20058,288,415► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20056,555,554► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 20116,281,230► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,431,598Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,440,194Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
8,822,499Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
7,977,357Polymorphic forms of 3-(4-amino-1-oxo-1, 3 dihydro-isoindo1-2-yl)-piperidine-2,6-dione► Subscribe
8,207,200Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroindol-2-yl)-piperidine-2,6-dione follow by autologous stem cell transplantation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
Hong Kong1143360► Subscribe
China102584788► Subscribe
South Korea100923173► Subscribe
Spain2304509► Subscribe
China103495169► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
C0056France► SubscribePRODUCT NAME: IENALIDOMIDE EVENTUELLEMENT SOUS LA FORME D?UN DE SES SELS D?ADDITION D?ACIDES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/391/001 DU 20070614; REGISTRATION NO/DATE AT EEC: EU/1/07/391/001-004 DU 20070614
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
2007 00054Denmark► Subscribe
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
AstraZeneca
Healthtrust
Chinese Patent Office
McKesson
McKinsey
Merck
US Army
Federal Trade Commission
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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